# K981217: Platinum Reading, Review & Analysis Workstation

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jun 18, 1998 after 76 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
355 later devices descend from it; 3 cite it directly.
1 of 356 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GE Medical Systems PACS Image Display Workstations: named in the summary without a submission number
- (no number) GE Medical Systems PACS Image Acquisition Workstations: named in the summary without a submission number
- (no number) GE Medical Systems PACS Network Storage Products: named in the summary without a submission number
- (no number) GE Medical Systems PACS LiteBox: named in the summary without a submission number
- (no number) GE Medical Systems Advantage Windows Review Workstation: named in the summary without a submission number
- (no number) ISG Technologies’ ISG Viewing and Reading Stations (VRS): named in the summary without a submission number
- (no number) ISG Technologies’ ISG Silhouette Radiology Application products: named in the summary without a submission number

## Most influential descendants
- K023557: Centricity Pacs Plus (2002), 354 descendants of its own
- K043415: Centricity Pacs System (2005), 324 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K103576: Mim 5.2 (Brachy) (2011), 79 descendants of its own

## Indications for use
The PLATINUM Image Reading, Review & Analysis Workstation is an image display workstation that is intended for use by qualified physicians for reading, reviewing and analyzing computerized digital images and reports acquired from imaging devices such as CT, MRI or computed radiography systems. PLATINUM is used to view digital images which are obtained either from a GE PACS System or a DICOM device, i.e. Acquisition, Archive or Workstation.

Source page: https://510kreport.com/device/K981217
Methodology: https://510kreport.com/methodology